Johnson & Johnson Seeks FDA Approval for DARZALEX FASPRO® in Expanded Treatment Regimens

Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the FDA for DARZALEX FASPRO®, seeking approval for a new indication. The application is for its use in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation, and with lenalidomide (D-R) for maintenance in newly diagnosed adult patients eligible for autologous stem cell transplant. The submission is supported by positive data from the Phase 3 PERSEUS study, demonstrating significant progression-free survival benefits and a consistent safety profile.